studies

596A AASLD ABSTRACTS HEPATOLOGY, October, 2015
sis may lead to an underestimation of the degree of fibrosis by
TE. Further studies are needed to investigate the correlation of
SWE measurements with liver fibrosis and steatosis assessed
with biopsy.
Disclosures:
Alfredo Alberti - Advisory Committees or Review Panels: Merck, roche, Gilead,
Merck, roche, Gilead, Merck, roche, Gilead, Merck, roche, Gilead; Grant/
Research Support: Merck, gilead, Merck, gilead, Merck, gilead, Merck, gilead;
Speaking and Teaching: novartis, BMS, novartis, BMS, novartis, BMS, novartis,
BMS
Paolo Angeli - Advisory Committees or Review Panels: Sequana Medical
The following authors have nothing to disclose: Silvia Tonello, Paola Bizzotto,
Sara Piovesan, Antonietta Romano, Georgios Anastassopoulos, Marta Tonon,
Giancarlo Bombonato
776
ELF Test Thresholds for disease stratification and prognosis
in chronic liver disease.
James W. Day 1 , William M. Rosenberg 1 , Julie Parkes 1,2 ; 1 Institute
for Liver and Digestive Health, University College London, London,
United Kingdom; 2 Public Health Sciences and Medical Statistics,
University of Southampton, Southampton, United Kingdom
BACKGROUND: Clinically meaningful categories of liver fibrosis
have traditionally been based on histological staging of
liver biopsies into mild, moderate and severe fibrosis, and
cirrhosis. Categorization by disease severity is used to stratify
patients and carries prognostic significance. Non-invasive
blood tests for liver fibrosis generate scores that may track
fibrosis across the categorical stages defined by histology. As
they are continuous variables they have the potential to provide
information about fibrosis and prognosis between as well as at
the thresholds defined by histology. We have investigated the
performance of the ELF test both at, and between the manufacturer’s
thresholds and determined the associated prognosis.
In addition we have identified a more specific threshold for
cirrhosis. METHODS: A cohort of 1,000 patients with mixed
chronic liver disease was used to evaluate the performance of
the manufacturer’s recommended thresholds of ELF score. An
additional threshold for detecting cirrhosis with 97% specificity
was derived by analyzing the ROC performance of ELF in this
cohort. These same thresholds were then used to determine the
time to first incidence of a liver related event (bleeding varices,
ascites, encephalopathy, hepatocellular cancer, liver transplantation
or liver related death) in a subset of 460 patients from
the cohort followed up for 7 years. RESULTS: Ruling-out fibrosis:
Fewer than 15% of patients with liver fibrosis >S1/6 will have
an ELF score 9.8 has a specificity to rule in S5,6 with only a
10% false positive rate and a score >11.3 has 97% specificity
for cirrhosis. An increase in the ELF score of 0.8 is associated
with a clinically significant difference in histological severity
of fibrosis. Prognosis: The risk of a liver related event within 5
years was approximately 2%, 30% and 50% respectively for
patients with ELF scores in the range 7.7-9.79, 9.8-11.29 and
≥11.3 ELF respectively. CONCLUSIONS: The ELF thresholds
7.7, and 9.8 stratify patients with CLD into clinically meaningful
groups for disease severity and prognosis. The ELF test
threshold of 11.3 improves specificity for cirrhosis and adds
meaningful prognostic information. The use of a continuous
variable score to assess liver fibrosis permits more refined stratification
of fibrosis severity than histological staging.
Disclosures:
William M. Rosenberg - Advisory Committees or Review Panels: Janssen, Merk,
Gilead, Merk, Gilead, GSK; Board Membership: iQur Limited, iQur Limited;
Consulting: siemens; Speaking and Teaching: siemens, Roche
Julie Parkes - Stock Shareholder: iQur (spouse is shareholder)
The following authors have nothing to disclose: James W. Day
777
Changes in liver stiffness by transient elastography (TE)
and serum lysyl oxidase-like-2 (sLOXL2) in patients with
cirrhosis treated with ledipasvir/sofosbuvir (LDV/SOF)-
based therapy
Marc Bourlière 1 , Veronique Loustaud-Ratti 2 , Sophie Metivier 3 ,
Vincent Leroy 4 , Armando Abergel 5 , Robert P. Myers 6 , Raul E.
Aguilar Schall 6 , Robert H. Hyland 6 , Mani Subramanian 6 , John
G. McHutchison 6 , Lawrence Serfaty 7 , Victor de Ledinghen 8 ;
1 Hépato-Gastro-Entérologie, Hôpital Saint Joseph, Marseilles,
France; 2 Recherche Clinique et de l’Innovation, CHU de Limoges
and Inserm UMR 1092, Université de Limoges, Limoges, France;
3 Service d’Hépato-Gastro-Entérologie, Hôpital Purpan, Toulouse,
France; 4 Hépato-Gastro-Entérologie, CHU de Grenboble, Grenoble,
France; 5 Médecine Digestive, CHU Estaing, Clermont-Ferrand,
France; 6 Gilead Sciences, Inc., Foster City, CA; 7 Hépatologie,
Hôpital Saint Antoine, Paris, France; 8 Service d’Hépato-Gastro-Entérologie
et d’Oncologie Digestive, CHU de Bordeaux, Pessac,
France
Background: Liver stiffness measurement (LSM) by TE is routinely
used to monitor HCV-related fibrosis. Our aim was to
explore changes in liver stiffness and a novel fibrosis marker,
sLOXL2, in cirrhotic patients with a sustained virologic response
(SVR) to SOF/LDV-based therapy. Methods: The study included
adults with HCV cirrhosis who achieved an SVR in the SIR-
IUS trial comparing LDV/SOF+ribavirin for 12 weeks vs. LDV/
SOF for 24 weeks. All patients had cirrhosis defined by liver
biopsy, or LSM by TE >12.5 kPa (FibroScan®; Echosens; Paris,
France), or Fibrotest >0.75 and APRI >2.0. TE was performed
at baseline (BL) and at the SVR24 time point, and sLOXL2
was measured by immunoassay (VIDAS® LOXL2; bioMérieux,
Marcy L’Etoile, France). The estimated stage of fibrosis based
on TE at BL and SVR24 was categorized as F0-2 (